Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors

Overview

The purpose of this study is to determine if High-dose 111In-Pentetreotide known as NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.

Full Title of Study: “High Dose Indium-111 Pentetreotide Therapy in Somatostatin Receptor Expressing Neuroendocrine Neoplasms.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 30, 2014

Interventions

  • Drug: Indium-111 pentetreotide
    • 4 cycles of 500 mCi treatments every 10-12 weeks

Arms, Groups and Cohorts

  • Experimental: Indium-111 pentetreotide
    • 4 cycles of 500 mCi treatments every 10-12 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Change in solid tumor dimensions by CT scan.
    • Time Frame: Baseline to post treatment CT scan performed 2-4 days after each cycle and 12and 24 weeks after treatments
    • Change in diameters of measurable lesions on CT using RECIST. and will be classified into 4 groups. Complete response Partial response No change or stable disease Progression

Secondary Measures

  • Frequency and severity of adverse events
    • Time Frame: up to 6 months following the last cycle of therap
    • Frequency and severity of adverse events. All adverse events will be graded using NCI common toxicities criteria

Participating in This Clinical Trial

Inclusion Criteria

  • Patients must have received first line standard chemotherapy and/or radiation therapy for neuroendocrine malignancy in the past and failed the therapy. – Patients must have evidence of residual multifocal active tumor. – All patients must sign an informed consent indicating the awareness of the investigational nature of the studies involved. – All patients must have a Karnofsky performance status of at least 60. – Patients must be greater than 18 years of age. – Patients must have measurable and/or followable disease based on either clinical or radiologic exam. – Sensitivity to Indium-111 pentetreotide or any of its components is an absolute contraindication to participation in this trial. – An absolute contraindication is pregnancy as evidenced by the clinical condition, a positive pregnancy test (Beta type Human chorionic gonadotropin (β-HCG) or pelvic ultrasound). – If patients have received prior radionuclide therapy of the same product, there must be documented response to that therapy and/or residual active stable disease. Exclusion Criteria:

  • Karnofsky performance status of 50 or less. – Patients who are unable to give informed consent. – Patients under 18 years of age. There will be no upper age discrimination. – Patients who are pregnant or those potentially pregnant subjects not willing to practice effective contraceptive techniques during the study period. – Patients with renal insufficiency as defined by a calculated creatinine clearance (based on age, weight and serum creatinine) of 39.9 ml/min or less.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Radio Isotope Therapy of America
  • Collaborator
    • Excel Diagnostic Imaging Clinics
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ebrahim Delpassand, President and CEO – Radio Isotope Therapy of America
  • Overall Official(s)
    • Ebrahim Delpassand, M.D., Principal Investigator, RITA Foundation

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